Cefox

Leaflet attached to the packaging: patient information

Cefox, 250 mg, film-coated tablets

Cefox, 500 mg, film-coated tablets

(Cefuroxime)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Cefox and what is it used for
• 2. Important information before taking Cefox
• 3. How to take Cefox
• 4. Possible side effects
• 5. How to store Cefox
• 6. Contents of the pack and other information

1. What is Cefox and what is it used for

Cefox is an antibiotic used in adults and children. The medicine works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Cefox is used to treat infections:

• throat
• sinuses
• middle ear
• lungs or chest
• urinary tract
• skin and soft tissues.

Cefox may also be used:

• to treat early stages of Lyme disease (borreliosis - an infection transmitted by ticks).

Your doctor may check what type of bacteria is causing your infection, and also check during treatment if the bacteria are sensitive to Cefox.

2. Important information before taking Cefox

When not to take Cefox:

• if you are allergic (hypersensitive) to cephalosporin antibiotics or any of the other ingredients of Cefox (listed in section 6);
• if you have ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams or carbapenems).

If any of the above applies to you, do not take Cefox without consulting your doctor.

Warnings and precautions

Cefox is not recommended for use in children under 3 months of age, as the safety and efficacy of the medicine in this age group are not known.
During treatment with Cefox, pay attention to whether you experience any of the following symptoms:
allergic reactions, fungal infections (e.g. thrush) and severe diarrhea (pseudomembranous colitis). This will reduce the risk of complications. See "Symptoms to watch out for" in section 4.

Blood tests

Cefox may affect the results of blood tests for sugar and a blood test called the Coombs test.
If you are going to have a blood test, tell the person taking the sample that you are taking Cefox.

Cefox and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about any medicines you plan to take. This includes medicines that are available without a prescription.

• Medicines that reduce stomach acid (e.g. antacids used to treat heartburn) may affect the action of Cefox.
• Probenecid (a medicine used to treat gout and other conditions).
• Oral anticoagulants (blood thinners).

If you are taking any of the above (or similar) medicines, tell your doctor.

Oral contraceptives

Cefox may reduce the effectiveness of oral contraceptives. If you are taking oral contraceptives while taking Cefox, you should also use a barrier method of contraception (e.g. condoms). If you are unsure, consult your doctor.

Pregnancy, breastfeeding and fertility

Tell your doctor before taking Cefox:

• if you are pregnant, think you may be pregnant or plan to become pregnant;
• if you are breastfeeding.

Your doctor will assess whether the benefits of taking Cefox during pregnancy and breastfeeding outweigh the risks to the baby.

Driving and using machines

Cefox may cause dizziness and other side effects that may impair your alertness.
You should not drive or operate machinery if you do not feel well.

3. How to take Cefox

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Cefox should be taken after a meal. This will help increase the effectiveness of the treatment.
Swallow the Cefox tablets whole with water.
Do not chew, crush or break the tablets - this may reduce the effectiveness of the treatment.

Usual dose

Adults
The usual dose of Cefox is 250 mg to 500 mg twice a day, depending on the severity and type of infection.
Children
The usual dose of Cefox is 10 mg/kg body weight (not more than 125 mg) to 15 mg/kg body weight (not more than 250 mg) twice a day, depending on:

• the severity and type of infection.

Cefox is not recommended for use in children under 3 months of age, as the safety and efficacy of the medicine in this age group are not known. In children who cannot swallow tablets, cefuroxime is used in the form of an oral suspension.
Depending on the disease and how the patient responds to treatment, the initial dose may be changed or more than one treatment cycle may be necessary.
Treatment duration
The treatment duration will be determined by your doctor, depending on the severity and type of infection. Follow your doctor's instructions.
Patients with kidney disease
If you have kidney disease, your doctor may change the dose of Cefox.
If this applies to you, tell your doctor.

Taking a higher dose of Cefox than recommended

If you take more Cefox than you should, you may experience neurological disorders, in particular, the risk of seizures (epileptic fits) increases.
Contact your doctor or emergency services immediately. If possible, show them the Cefox packaging.

Missing a dose of Cefox

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

Stopping treatment with Cefox

It is important not to shorten the prescribed treatment period with Cefox. Do not stop treatment without your doctor's advice, even if you feel better. Shortening the recommended treatment period may lead to a recurrence of the disease.

4. Possible side effects

Like all medicines, Cefox can cause side effects, although not everybody gets them.

Symptoms to watch out for

In a small number of people taking Cefox, an allergic reaction or potentially serious skin reaction has been reported. The symptoms may be:

• severe allergic reaction; symptoms include: a raised, itchy rash, swelling, sometimes of the face or lips, which may make breathing difficult;
• skin rashthat may develop into blisters and look like small rings (a dark spot in the center surrounded by a lighter border with a dark ring around the edge);
• widespread skin changes with blisters and peeling skin(this may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis).

Other symptoms to watch out for while taking Cefox:

• fungal infections; medicines like Cefox can cause an overgrowth of thrush (Candida) in the body, leading to a fungal infection (e.g. thrush); the risk of this side effect is greater if Cefox is used for a long time;
• severe diarrhea(pseudomembranous colitis); medicines like Cefox can cause inflammation of the colon (large intestine), leading to severe diarrhea, usually with blood and mucus, abdominal pain and fever;
• Jarisch-Herxheimer reaction; when taking Cefox to treat Lyme disease (borreliosis), some patients may experience a high temperature (fever), chills, muscle and headache, and a rash; this is known as a Jarisch-Herxheimer reaction; these symptoms usually last from a few hours to a day.

If you experience any of these symptoms, contact your doctor or nurse immediately.

Common side effects

May affect up to 1 in 10 people:

• fungal infections (e.g. thrush),
• headache,
• dizziness,
• diarrhea,
• nausea,
• stomach pain.

Common side effects that may be seen in blood tests:

• increased white blood cell count (eosinophilia),
• increased liver enzyme activity.

Uncommon side effects

May affect up to 1 in 100 people:

• vomiting,
• skin rashes.

Uncommon side effects that may be seen in blood tests:

• decreased platelet count (cells involved in blood clotting),
• decreased white blood cell count (leukopenia),
• positive Coombs test result.

Other side effects

Other side effects occur in a very small number of patients, but the exact frequency is not known:

• severe diarrhea (pseudomembranous colitis),
• allergic reactions,
• skin reactions (including severe),
• high temperature (fever),
• yellowing of the whites of the eyes or skin,
• liver inflammation.

Side effects that may be seen in blood tests:

• rapid breakdown of red blood cells (hemolytic anemia).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist or nurse . Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309,
e-mail: ndl@urpl.gov.pl .
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cefox

Keep this medicine out of the sight and reach of children.
There are no special storage precautions.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cefox contains

The active substance is cefuroxime (in the form of cefuroxime axetil).
Cefox, 250 mg - one film-coated tablet contains 250 mg of cefuroxime in the form of cefuroxime axetil.
Cefox, 500 mg - one film-coated tablet contains 500 mg of cefuroxime in the form of cefuroxime axetil.
The other ingredients are:
core ingredients- microcrystalline cellulose, croscarmellose sodium (PH-102), sodium lauryl sulfate, anhydrous colloidal silica, hydrogenated vegetable oil;
coating ingredients- hypromellose (5cP), titanium dioxide (E 171), macrogol 400.

What Cefox looks like and contents of the pack

Cefox, 250 mg: white or almost white, oblong, film-coated tablets, smooth on one side and with the inscription "A33" on the other.
Cefox, 500 mg: white or almost white, oblong, film-coated tablets, smooth on one side and with the inscription "A34" on the other.
PA/Aluminum/PVC/Aluminum blisters, in a cardboard box.
Pack sizes: 10, 14, 20 or 28 tablets.

Marketing authorization holder and importer

Marketing authorization holder:

S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków
Tel.: 71 330 50 80

Importer:

APL Swift Services (Malta) Limited
HF 26, Hal Far Industrial Estate, Hal Far, Birzebbugia
BBG 3000
Malta

Date of last revision of the leaflet: